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Trial record 1 of 5 for:    ampreloxetine
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Extension Study of Ampreloxetine (TD-9855) for Treating snOH in Subjects With Primary Autonomic Failure

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ClinicalTrials.gov Identifier: NCT04095793
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Tracking Information
First Submitted Date  ICMJE August 1, 2019
First Posted Date  ICMJE September 19, 2019
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE September 19, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2019)
  • Physical examination [ Time Frame: Baseline to Week 26 ]
    Number of subjects with new abnormalities reported on their physical exam.
  • Neurological Examination [ Time Frame: Baseline to Week 26 ]
    Number of subjects with new abnormalities reported on their neurological exam.
  • Vital Signs [ Time Frame: Baseline to Week 26 ]
    Number of subjects with clinically significant vital sign abnormalities.
  • ECGs [ Time Frame: Baseline to Week 26 ]
    Number of subjects with clinically significant ECG findings.
  • Clinical Laboratory Tests [ Time Frame: Baseline to Week 26 ]
    Number of subjects with laboratory test abnormalities.
  • Concomitant Medications [ Time Frame: Baseline to Week 26 ]
    Changes in concomitant medications
  • Adverse Events (AEs) [ Time Frame: Baseline to Week 26 ]
    Incidence and severity of treatment-emergent adverse events
  • Subject compliance to study treatment [ Time Frame: Baseline to Week 26 ]
    Number of subjects determined to be compliant with study medications.
  • Incidence of Falls [ Time Frame: Baseline to Week 26 ]
    Changes in incidence of falls
  • Changes from baseline in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline to Week 26 ]
    The C-SSRS is a tool designed to systematically assess and track suicidal AEs (suicidal behavior and suicidal ideation) and will be used for all visits.
Original Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • Physical examination [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with new abnormalities reported on their physical exam.
  • Neurological Examination [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with new abnormalities reported on their neurological exam.
  • Vital Signs [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with clinically significant vital sign abnormalities.
  • ECGs [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with clinically significant ECG findings.
  • Clinical Laboratory Tests [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects with laboratory test abnormalities.
  • Concomitant Medications [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Changes in concomitant medications
  • Adverse Events (AEs) [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Incidence and severity of treatment-emergent adverse events
  • Subject compliance to study treatment [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Number of subjects determined to be compliant with study medications.
  • Incidence of Falls [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    Changes in incidence of falls
  • Changes from baseline in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline to Day 197 (over a 26 week period) ]
    The C-SSRS is a tool designed to systematically assess and track suicidal AEs (suicidal behavior and suicidal ideation) and will be used for all visits.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study of Ampreloxetine (TD-9855) for Treating snOH in Subjects With Primary Autonomic Failure
Official Title  ICMJE A Phase 3, 182-week, Open-Label, Safety and Tolerability Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (snOH) in Subjects With Primary Autonomic Failure
Brief Summary A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and snOH over 182 weeks.
Detailed Description This is a Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and snOH. The study consists of 3 periods: (i) 26-week treatment, (ii) 156-week treatment extension, and (iii) 2-week follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Symptomatic Neurogenic Orthostatic Hypotension
Intervention  ICMJE Drug: ampreloxetine
Oral tablet, QD
Other Name: TD-9855
Study Arms  ICMJE Experimental: ampreloxetine
Participants will receive a single, oral, daily dose of active drug (TD-9855) for 182 weeks.
Intervention: Drug: ampreloxetine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completion of Study 0170 and, in the opinion of the Investigator, would benefit from long-term treatment with ampreloxetine.
  • The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study procedures (including any changes occurring in the subject's current therapeutic regimen).
  • The subject must be willing to continue on treatment and must continue to meet all the inclusion criteria for the preceding study (Study 0170) except, a score of >4 in OHSA#1.

Exclusion Criteria:

  • Subjects may not be enrolled in another clinical trial.
  • Psychiatric, neurological, or behavioral disorders that may interfere with the ability of subjects to give informed consent, or interfere with the conduct of the study.
  • Medical, laboratory, or surgical issues deemed by the Investigator to be clinically significant.
  • Hypersensitivity to ampreloxetine or the formulation excipients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Theravance Biopharma Call Center 1-855-633-8479 medinfo@theravance.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04095793
Other Study ID Numbers  ICMJE 0171
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Responsible Party Theravance Biopharma
Study Sponsor  ICMJE Theravance Biopharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Theravance Biopharma
PRS Account Theravance Biopharma
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP